GlaxoSmithKline announced that the FDA has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old. The new indication reflects emerging research showing the combination of the two medicines treats the symptoms of enlarged prostate more effectively than either medicine alone. “The combination of AVODART and tamsulosin at diagnosis allows doctors to simultaneously treat the patient’s prostate on two fronts by reducing prostate size and rapidly improving symptoms,” said Steven A. Kaplan, M.D., from Weill Cornell Medical College of Cornell University in New York City. Common symptoms of enlarged prostate include nocturia, frequent and urgent urination, incomplete emptying, starting and stopping, and weak stream. If left untreated, enlarged prostate can lead to hospitalization for the inability to urinate or prostate surgery. AVODART already had been approved by the FDA for the treatment of enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery. Tamsulosin, an alpha-blocker, already had been indicated for the treatment of the signs and symptoms of enlarged prostate. The FDA approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate. The CombAT study is the first long-term assessment of the combination of AVODART and an alpha-blocker. Study results were first presented in September 2007 at the 29th annual meeting of the Societe Internationale d’Urologie in Paris. The study was published in the February issue of the Journal of Urology. The CombAT study results showed that combination therapy with AVODART and tamsulosin was superior to both monotherapies at Month 12 and continued to Month 24. The primary endpoint was the change in International Prostate Symptom Score (IPSS) from baseline at Month 24 for combination therapy compared to each medication alone. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Data from the remaining 2 years of the CombAT study will provide further information on the pattern of symptoms and long-term outcomes associated with combination therapy vs. AVODART and tamsulosin monotherapies.
